EXCLUSIVE: Sanofi Pasteur US CMO Says U.S. Regulators Most Interested in Four-Strain Flu Vax

EXCLUSIVE: Sanofi US CMO Says U.S. Regulators Most Interested in Four-Strain Flu Vax

December 18, 2014

By Riley McDermid, BioSpace.com Breaking News Sr. Editor

American health authorities were the first to express an interest in a quadrivalent flu vaccine and so Sanofi Pasteur decided to debut their new four-strain drug, Fluzone, in the U.S. first, David Greenberg, chief medical officer for Sanofi Pasteur US , told BioSpace this week.

“The U.S. public health authorities are the primary groups who have expressed interest in a quadrivalent vaccine, thus we filed in the United States first and may follow in other countries based on regulatory and market conditions,” he said in an interview.

Fluzone Intradermal Quadrivalent will be available in the United States for the 2015/16 influenza season.

“It is the first and only four-strain influenza vaccine option administered intradermally,” Greenberg told BioSpace. “It was developed to help address frequent B-strain mismatches and broaden coverage against influenza by incorporating a strain from each B lineage.”

The intradermal device is designed for easy delivery and administration to help deliver influenza vaccine just under the skin surface, while saving time for both immunizers and patients, he said.

“The approval of Fluzone Intradermal Quadrivalent comes at a time when Sanofi Pasteur is gradually transitioning all Fluzone vaccine from trivalent to Quadrivalent,” said Greenberg.

Sanofi Pasteur would know how to shepherd a new product through the American regulatory system: It is the largest U.S. influenza vaccine supplier, providing a broad Fluzone vaccine product portfolio to help address the unique immunizations needs of all age groups, from children as young as six months through adults 65 years of age and older.

“For the 2014/2105 influenza season, we supplied approximately 65 million doses of Fluzone vaccine in the U.S., including Fluzone High-Dose vaccine, which was introduced in 2010, is indicated for adults 65 years of age and older, Fluzone vaccine in two presentations: a 0.5 mL prefilled syringe and a 5 mL multi-dose vial, and Fluzone Quadrivalent vaccine, which helps protect against four influenza strains (two A strains and two B strains),” said Greenberg.

Greenberg was tight-lipped about rumors that in this "Ebola climate" the U.S. Food and Drug Administration has been more willing and responsive to vaccine treatments of all sorts.

“The product was approved according to the timing we were provided when we filed with the FDA during the first quarter of 2014,” he said, as he declined to comment on a ballpark sales market figure for this vaccine. “We do not comment on sales projections for competitive reasons,” said Greenberg.

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